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Effects of Melatonin on Non-alcoholic fatty liver disease

Not Applicable
Recruiting
Conditions
onalcoholic fatty liver disease (NAFLD).
nonalcoholic steatohepatitis
Registration Number
IRCT2016061516123N8
Lead Sponsor
Vice Chancellor for Research and Technology, Ahvaz Jundishapur University of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
50
Inclusion Criteria

A - Age 18 years and older; with evidence of nonalcoholic fatty liver in ultrasonography with a higher degrees and equal 2 of steatosis; the liver enzyme concentration (alanine aminotransferase or ALT) greater than 1.5 times the highest normal.
b -exclusion criteria: history of alcohol consumption; chronic and acute liver disorders (hepatitis B, C, ...); biliary diseases; autoimmune diseases; cancer; hereditary disorders affecting on liver condition (storage disease of iron, copper, ...); cardiovascular; pulmonary diseases; kidney diseases; pregnancy; breast-feeding; use of contraceptives; hepatotoxic drugs consumption; use of Mineral- multivitamin supplements; weight loss surgery in the past year; weight loss program in 3 month ago; history of hypothyroidism; Cushing's syndrome.

Exclusion Criteria

Not provided

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Alanine transaminase. Timepoint: before intervention and after 3 months. Method of measurement: seum level.;Aspartate transaminase. Timepoint: before intervention and after 3 months. Method of measurement: serum level.;Tumor necrosis factor alpha. Timepoint: before intervention and after 3 months. Method of measurement: serum level.;High sensitive C reactive protein. Timepoint: before intervention and after 3 months. Method of measurement: serum level.;Triglyceride. Timepoint: before intervention and after 3 months. Method of measurement: serum level.;Total cholesterol. Timepoint: before intervention and after 3 months. Method of measurement: serum level.;Low density lipoprotein (LDL). Timepoint: before intervention and after 3 months. Method of measurement: serum level.;High density lipoprotein (HDL). Timepoint: before intervention and after 3 months. Method of measurement: serum level.
Secondary Outcome Measures
NameTimeMethod
Sleep quality. Timepoint: before and 3 months after intervention. Method of measurement: Pittsburgh sleep quality index questionnaire.
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